BEDMINSTER, N.J., July 28, 2011 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that Ramona M. Lloyd, Ph.D., RAC, has joined the Company as Vice President Regulatory Affairs, effective immediately. In this newly created position, Dr. Lloyd will be responsible for the management of all regulatory activities, including regulatory strategy and interactions with the U.S. Food & Drug Administration, as the Company completes its Phase III efforts and prepares for anticipated regulatory filings. Dr. Lloyd will report directly to Chief Operating Officer, Drs. Ben Machielse.
Commenting on today's news, Drs. Machielse stated, "Ramona brings more than 19 years of global regulatory experience with investigational and marketed products in both multi-national pharmaceutical and biotech companies. In particular, her proven ability to develop and drive the execution of global regulatory strategies for companies including, Ethicon Inc., Imclone Systems Inc. and Bristol-Myers Squibb will be key as Omthera moves ahead with the development and potential commercialization of our first product, Epanova™."
Prior to joining Omthera, Dr. Lloyd served as Vice President, Regulatory Affairs for Ethicon Inc., a Johnson & Johnson company, where she was instrumental in driving the growth of the company's Wound Management Business Unit. Prior, Dr. Lloyd held positions at Imclone Systems Inc., a wholly-owned subsidiary of Eli Lilly and Company, including, Interim Senior Vice President, Global Regulatory Affairs and Drug Safety as well as Vice President, Regulatory Affairs-Late Development. While at Imclone, among other activities, Dr. Lloyd directed the development, implementation and execution of global regulatory strategies for the successful conduct of broad Phase II and Phase III studies for all monoclonal antibody pipeline projects. Dr. Lloyd's extensive industry experience also includes such positions as, Vice President, Worldwide Regulatory Affairs and Quality Compliance for GPC Biotech Inc., and Vice President, Global Regulatory Operations for Bristol-Myers Squibb.
Dr. Lloyd is the author of numerous industry publications. She currently serves as a Member of the Industrial Advisory Board, Department of Biomedical Engineering at Rutgers University. Dr. Lloyd, who is Regulatory Affairs Certified (RAC), holds a Ph.D. in Molecular Genetics and Microbiology from Rutgers University and UMDNJ (Center for Advanced Biotechnology and Medicine, New Brunswick, NJ) and a B.S. degree in Biochemistry from the University of Massachusetts.
About Omthera Pharmaceuticals, Inc.
Founded in 2008, Omthera Pharmaceuticals, Inc. is a privately-held, emerging specialty pharmaceuticals company focusing its efforts on the clinical development of new therapies for dyslipidemia. Led by a team of experts with exceptional experience in developing new therapies for lipid disorders, Omthera is dedicated to developing innovative therapies for the millions of patients who have elevated triglyceride levels and increased risk of cardiovascular disease. In March 2011, the Company initiated a pivotal Phase III clinical trial for its lead product candidate, Epanova™, an Omega-3 fatty acid compound in development as a triglyceride-lowering adjunct therapy to diet in patients with very high triglycerides (greater than or equal to 500 mg/dL). Future planned clinical trials for Epanova include patients with high triglycerides (greater than or equal to 200 mg/dL and less than or equal to 500 mg/dL) currently on statin therapy. For more information, please visit www.omthera.com.
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